DeviceClearance

Product code EMB— Dental

DEN TEMP

Classification name
Zinc Oxide Eugenol
Device class
Class 1
Regulation
21 CFR 872.3275
Advisory panel
Dental
Total cleared
11
First cleared
Most recent

Market context for product code EMB

FDA has cleared 11 devices under product code EMB between 1978 and 2016, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code EMB

Recent clearances under product code EMB

Data sourced from openFDA. This site is unofficial and independent of the FDA.